Loading...
•
Dec 31, 2023
Xenon Pharmaceuticals Q4 2023 Earnings Report
Xenon Pharmaceuticals reported financial results for Q4 2023 and provided a corporate update.
Key Takeaways
Xenon Pharmaceuticals reported a net loss of $44.7 million for the fourth quarter of 2023. The company's cash and cash equivalents and marketable securities were $930.9 million as of December 31, 2023, expected to fund operations into 2027. The company is advancing its XEN1101 program in epilepsy and major depressive disorder.
XEN1101 Phase 3 epilepsy program continues to progress with X-TOLE2 and X-TOLE3 in focal onset seizures and X-ACKT in primary generalized tonic-clonic seizures; completion of patient enrollment in X-TOLE2 expected in late 2024 to early 2025.
Planned “end-of-Phase 2” meeting with the FDA in April to support the initiation of XEN1101 Phase 3 program in major depressive disorder in the second half of the year.
Strong financial position with approximately $930 million to fully support XEN1101 Phase 3 programs in epilepsy and major depressive disorder and expected cash runway into 2027.
The company continues to evaluate other neurological indications that present a potential fit for XEN1101’s novel mechanism and product profile.
Xenon Pharmaceuticals
Xenon Pharmaceuticals
Forward Guidance
Xenon anticipates patient enrollment in X-TOLE2 will be completed in late 2024 to early 2025. Xenon anticipates participating in an “end-of-Phase 2” meeting with the U.S. Food and Drug Administration in April to support the initiation of its late-stage XEN1101 clinical program in MDD, which will include three Phase 3 clinical trials, with the first Phase 3 study expected to initiate in the second half of 2024.
Positive Outlook
- Completion of patient enrollment in X-TOLE2 expected in late 2024 to early 2025.
- Planned “end-of-Phase 2” meeting with the FDA in April to support the initiation of XEN1101 Phase 3 program in major depressive disorder in the second half of the year.
- Strong financial position with approximately $930 million to fully support XEN1101 Phase 3 programs in epilepsy and major depressive disorder and expected cash runway into 2027.
- Advancing XEN1101 in major depressive disorder with plans to conduct an end-of-Phase 2 meeting with the FDA in April, and we expect to initiate our Phase 3 program in the second half of this year.
- We also continue to evaluate other neurological indications that present a potential fit for XEN1101’s novel mechanism and product profile.
Challenges Ahead
- Clinical trials may not demonstrate safety and efficacy of any of our or our collaborators’ product candidates.
- Promising results from pre-clinical development activities or early clinical trial results may not be replicated in later clinical trials.
- Our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect.
- Any of our or our collaborators’ product candidates, including XEN1101, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable.
- Regulatory agencies may impose additional requirements or delay the initiation of clinical trials.